Although there are strain rate imaging products on the market today, none are able to provide real-time, regionally-specific, quantitative measurements of myocardium mechanics in multiple dimensions. Doppler- based strain rate imaging (SRI) implementations compromise image quality in order to provide adequate signal to noise ratio strain rate images. In addition, accuracy of Doppler-based measurements suffers from angle dependency. Other current SRI implementations process stored B-mode data to track image speckle and other features to eliminate angle dependency issues;however, accuracy is limited since these methods only use amplitude data, and low frame acquisition rates can cause poor feature tracking. Pixel Velocity Inc. has developed a technology which overcomes these limitations and is capable of producing accurate, regional, quantitative measurements of heart dynamics and mechanics. During NIH-funded Phase I and Phase II SBIR grants, Pixel Velocity Inc., in collaboration with The University of Michigan Health System, University of Michigan Biomedical Engineering Department and WinProbe Corporation, built a prototype of the real-time two-dimensional strain rate imaging ultrasound and demonstrated the performance of the system via a 20-patient human feasibility study. During the Phase II Competing Renewal project Pixel Velocity, The University of Michigan Health System and Regulatory Affairs Associates will seek FDA approval for the real-time, two-dimensional strain rate imaging system. This work includes establishing the necessary quality management system, conducting a series of clinical trials designed to demonstrate the safety and efficacy of Pixel's strain rate imaging technology, and submitting the associated FDA 510(k) applications for approval. The successful result will be FDA approval to market the Pixel Velocity real-time, two-dimensional strain rate imaging technology to quantitatively measure regional myocardium mechanical function, providing diagnostic information for selecting and guiding cardiac therapy. PUBLIC HEALTH RELEVANCE: A primary goal of clinical cardiology is assessment of heart muscle function. In particular, regional evaluation of myocardium expansion and contraction, or contractility, provides critical diagnostic and therapeutic information. Pixel Velocity's real-time, two-dimensional strain rate imaging system will offer cardiologists fast and accurate means to quantify regional myocardium mechanical function, enabling cardiologists to improve diagnosis, treatment, and risk stratification of patients with coronary artery disease.